The Benefits of a Pilot Study Before a GLP Study
Jul 23, 2014
The challenge of getting a medical device from research to clinical application can be significant, especially when studies must meet GLP requirements. While it is difficult to deny the overall desirability, especially for regulators, of GLP standards, meeting such requirements demands much of researchers, as well as those who are backing their efforts. For individuals and organizations in the process of planning a GLP study, it may appear desirable to begin as soon as possible. It is a given that the study will take some time, and the sooner it is begun, the sooner it will be completed. However, it may be worthwhile to consider running a pilot study beforehand.
Conducting a pilot study before a GLP study has several advantages. In the long run, a pilot study can actually save time and money, as well as improve the overall accuracy of the official GLP study. Consider these advantages:
GLP studies are designed so that any sufficiently trained scientist can reproduce the same results using said documentation. This requires that every step of the study must be documented in extensive detail. This certainly has its usefulness, but in a situation where there are any uncertainties about how the study will be conducted, this level of documentation can become time consuming.
A pilot study allows researchers to test the waters before fully committing their efforts to the documentation efforts demanded of a GLP study. This trial and error allows for the construction of a study that is truly prepared for the GLP process, with a well-defined path and processes. With less false trails to go down, the actual GLP study will be more focused, and thus faster, than it would be without a previous pilot study.
Just as a pilot study can save time, it can also increase the accuracy of the subsequent GLP study. Good research is a process of continuous trial and error, and a pilot study allows for researchers to push through some of those errors before the serious documentation process even begins. This results in a GLP study that is more focused, and gives researchers a better understanding of the parameters of their study.
The purpose of any study is to produce an accurate result, and pilot studies help improve accuracy. By the time the GLP study is conducted, both the methods and understanding of researchers will have improved.
Saving on expense
GLP studies, as a result of the substantial amount of documentation that goes into them, can become quite expensive. Every action taken in the process of a GLP study must be documented by researchers. This included every failure in each experiment. While this is useful for regulators, it can be expensive for those funding the research. With each subsequent step taken in the experiment, the cost grows in documentation alone.
A pilot study allows researchers to get many of these discovery efforts out of the way, without the burden of GLP documentation standards. This saves money. When the actual GLP study is conducted, the focus achieved from the pilot study will reduce expenses, both as a result of time saved and the reduced amounts of documentation required.
Perfect for trial and error
A pilot study is not subject to review by the FDA. This makes it perfect for the trial and error process, as the FDA will not have access to any information obtained in the study. This way, when the actual GLP study is conducted, it can be designed with FDA scrutiny in mind.
For an improved GLP study
GLP studies are a necessary component of device development, but they are best conducted only after significant planning has been conducted. Through the use of pilot studies beforehand, it is possible to refine the quality of the subsequent GLP studies, thus saving on time and expense. While it there may be some pressure to begin the GLP process straight away, the advantages of a prior pilot study are certainly worth considering.